Feasibility and Utility of a Prehabilitation Program for Use in Patients With Benign Prostatic Hyperplasia Who Have Elected to Undergo Holmium Laser Enucleation of the Prostate (HoLEP).

April 22, 2026 updated by: Mark Assmus, University of Calgary

Evaluating the Feasibility of a Comprehensive Prehabilitation Program for Use in Benign Prostatic Hyperplasia Patients Undergoing Holmium Laser Enucleation of the Prostate

Benign prostatic hyperplasia (BPH) is a debilitating condition which is highly prevalent in older males, up to 45% of those over the age of 45 are affected and 80% of those over the age of 70 are affected. While not all men with BPH experience problematic symptoms, many will experience lower urinary tract symptoms (LUTS) including difficulty passing urine, recurrent urinary tract infections, bladder stones, and hematuria. Holmium Laser Enucleation of the Prostate (HoLEP) is the gold standard in terms of surgical BPH management and is associated with a low risk for requiring repeat interventions. However, in the weeks following HoLEP procedures many men will experience transient urinary incontinence which can be distressing to patients.

In the setting of prostate cancer, exercise and mental health supports prior to surgery has been shown to improve incontinence and post-surgical recovery. This is often termed prehabilitation and consists of programming done in the months before surgery. The objective of this study is to assess the safety and feasibility of prehabilitation programming prior to HoLEP procedures for men with BPH.

The investigators will be randomizing 40 patients into 2 groups, one receiving standard of care interventions prior to their HoLEP surgery and one receiving at least 12 weeks of comprehensive prehabilitation programming including: pelvic floor physiotherapy, access to additional informational resources, and access to mental health supports including individual and couples counselling. In both groups the investigators will be collecting key demographics and clinical information from patients as well as assessing their urinary function through several questionnaires before prehabilitation, immediately before surgery, and up to 1 year after surgery.

The investigators hope to establish that prehabilitation is a safe and feasible option for these patients. Secondarily investigators hope to provide evidence that prehabilitation improves incontinence faster following HoLEP procedures and improves post-surgical recovery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Southern Alberta Institute of Urology
        • Contact:
        • Principal Investigator:
          • Mark Assmus, MD, MPH, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Opting to undergo HoLEP procedure for the treatment of BPH
  2. Estimated prostate size (>60 ml)
  3. Have received permission to exercise from their primary care provider
  4. Access to a computer/ smartphone and internet access to complete associated questionnaires and access online educational resource

Exclusion Criteria:

1. Other medical or psychiatric conditions which preclude the ability to participate in exercise or utilize the online education module

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Participants in this arm will receive standard information and recommendations from a surgeon prior to HoLEP. These include recommendations to participate in exercise and information about what to expect with the procedure.
Active Comparator: Comprehensive Prehabilitation Programming
Participants in this arm will receive the standard of care recommendations from a urologist but will also complete a comprehensive prehabilitation program over 12-weeks within 5 months of the procedure.
Behavioral: Comprehensive Prehabilitation Programming
This prehabilitation program will include an exercise component consisting of once weekly pelvic floor physiotherapy sessions as well as recommendations to complete pelvic floor strengthening exercises and 150 minutes of moderate to intense cardiovascular exercise at home. Completion of these exercises will be self-reported biweekly through an exercise tracking form submitted to study staff. This program will also include access to a comprehensive online module with information about BPH and the HoLEP procedure. Lastly, this will consist of access to mental health supports including individual and couples counselling.
Other Names:
  • Exercise therapy
  • Mental Health Supports
  • Educational Resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates.
Time Frame: Only assessed at the pre-surgical follow-up (ie. from baseline to pre-surgery), between 1-4 weeks prior to surgery.
Feasibility will be assessed through a feasibility questionnaire administered only to participants in the intervention group prior to surgery. This questionnaire is a modified version of a previously established system usability scale which consists of 10 questions assessing the feasibility of the program which participants will rate on a 1-5 Likert scale. Four additional yes/no questions regarding feasibility for further assessment. Feasibility will also be assessed based on recruitment (with a goal of 30% of patients approached based on previous studies), adherence to the exercise protocol (with a goal of 70% adherence based on previous studies), and retention through the full 12-weeks of the intervention (with a goal of 80% based on previous studies.
Only assessed at the pre-surgical follow-up (ie. from baseline to pre-surgery), between 1-4 weeks prior to surgery.
Safety assessed through side effects of prehabilitation programming and reporting of adverse events.
Time Frame: To be administered every 3 weeks of the 12-week prehabilitation program starting with the 3rd week and ending with the 12th week.
Safety will be assessed through a modified version of safety questionnaires used in previously reported exercise and counselling studies. This will consist of 8 questions (graded on a 0-10 Likert scale) assessing the side effects of exercise programming, 4 questions (graded on a 0-10 Likert scale) assessing the side effects of mental health supports, and a question assessing adverse events. Any adverse events would be reported and graded minor (Grade ≤1 - not requiring medical intervention) or serious (Grade ≥2 - requiring medical intervention) based on previously established National Health Institute criteria.
To be administered every 3 weeks of the 12-week prehabilitation program starting with the 3rd week and ending with the 12th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
The IPSS is a 7 question screen for lower urinary tract symptoms with each question graded on a 0-5 Likert scale. Greater scores indicate more severe dysfunction with the following cutoffs: mild (0-7), moderate (8-19), or severe (20-35).
To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
Michigan Incontinence Symptom Index (M-ISI)
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
The M-ISI is a 10 item assessment of urinary incontinence symptoms with questions 1-8 being the total severity and questions 9 and 10 being the bother subsection of the questionnaire. Each question is graded on a 0-4 Likert scale with greater scores indicating more severe incontinence.
To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
Sexual Health Inventory for Men (SHIM)
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
The SHIM is a 5-item assessment of erectile dysfunction severity with each question scored on a 0-5 Likert scale and higher scores indicating better erectile function. The following score cutoffs are used to describe dysfunction: 1-7: Severe ED, 8-11: Moderate ED, 12-16: Mild to Moderate ED, 17-21: Mild ED, 22-25: Normal Function.
To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD)
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
The MSHQ-EjD is a 4-item assessment of ejaculatory dysfunction which is broken into a function score for the first 3 questions and a bother score for the last question. Each question is graded on a 0-5 Likert scale with higher scores indicating better ejaculatory function.
To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
Euroquol 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
The EQ-5D-5L is a 6-item assessment of quality of life. The first 5 items are graded on a 1-5 Likert scale with higher scores indicating worse quality of life. The last item is a 0-100 rating of overall health status with higher scores indicating better health.
To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.
Novel Incontinence Questionnaire
Time Frame: To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.
This is a questionnaire the investigators designed with yes/no questions to assess whether patients are experiencing any incontinence. Pre-surgery, the questionnaire is divided based on catheterization status - if a participant has a catheter it asks whether they had incontinence prior to catheterization and if a participant does not have a catheter it asks whether they currently have incontinence. Post-surgery, the questionnaire assesses whether the participant still has incontinence and if they report they do not, asks which week after surgery they stopped experiencing incontinence.
To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire Short Form (IPAQ-SS)
Time Frame: To be collected at baseline, every 3 weeks during the 12-week prehabilitation program (starting at week 3 and ending at week 12), and at 4-, 12-, and 26-weeks post-surgery.
This is a 7-item measure which collects information regarding the minutes of physical activity performed per week across different domains including: walking, mild activity, moderate activity, and strenuous activity. While patients are participating in the prehabilitation program an item will also be added for participants to report their adherence to home pelvic floor strengthening exercises and the questionnaire will be modified for them to report their 3-week physical activity average rather than only for a single week. This measure assesses minutes of physical activity per week so the minimum value is 0 minutes and the maximum value is 10080 minutes with greater values representing more physical activity. Each minute also has a multiplier applied for the metabolic equivalent of the task (METs) in order to generate a weekly number of METs. Again higher numbers are associated with more physical activity.
To be collected at baseline, every 3 weeks during the 12-week prehabilitation program (starting at week 3 and ending at week 12), and at 4-, 12-, and 26-weeks post-surgery.
Size of surgical specimen
Time Frame: Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Once pathology is available the weight of the prostate tissue resected in grams will be recorded.
Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Estimated pre-surgical prostate size
Time Frame: Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Prior to the procedure, imaging and cystoscopy notes will be reviewed to obtain an estimate of prostate size. In the case of conflicting sizes reported, the most recent size on imaging will be recorded.
Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Post-surgical catheterization
Time Frame: Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
The number of days each patient was catheterized after their HoLEP procedure.
Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Surgical complications
Time Frame: Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Any complications which occur during the surgery or post-operatively while still admitted will be recorded.
Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.
Pre-surgical complications of BPH
Time Frame: Pre-operative period beginning after study enrollment until the date of surgery, maximum of 20 weeks prior to surgery.
All complications relating to BPH requiring an emergency department visit or hospital admission will be recorded including the type of complication and duration of stay in the case of an admission.
Pre-operative period beginning after study enrollment until the date of surgery, maximum of 20 weeks prior to surgery.
Post-surgical outpatient complications
Time Frame: Post-discharge from HoLEP procedure until final follow-up, up to 52 weeks after surgery.
All complications relating to the HoLEP procedure or BPH after discharge from the hospital following HoLEP procedure will be recorded if requiring an emergency department visit or admission to hospital including the type of complication and duration of stay if admitted.
Post-discharge from HoLEP procedure until final follow-up, up to 52 weeks after surgery.
Duration of hospital stay
Time Frame: Peri-operative period, up to 4 weeks after surgery.
The number of days admitted for the HoLEP procedure will be recorded.
Peri-operative period, up to 4 weeks after surgery.
Post-void residual
Time Frame: From enrollment in the study until final follow-up, up to an 72 week period from 20 weeks prior to surgery until 52 weeks after.
All available post-void residuals will be recorded, this includes pre-operatively if performed as well as the post-void residual typically collected at discharge. If post-void residual is obtained at any post-operative clinic visits then this will be recorded as well.
From enrollment in the study until final follow-up, up to an 72 week period from 20 weeks prior to surgery until 52 weeks after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Calgary (RSO1020497)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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